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NCT04641650 Clinical Trial

Pilot Study : FreeStyle Libre Pro Flash Continuous Glucose Monitoring System in Subjects With Diabetes on HemoDIALsis

Diabetes Clinical Trial

— FSL DIAL  

Official title:
FreeStyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System in Subjects With Diabetes on HemoDIALsis (FSL-DIAL Pilot Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04641650
Other study ID # FSL DIAL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 21, 2021
Est. completion date November 9, 2022

Study information
Verified date April 2024
Source Centre Hospitalier Saint Joseph Saint Luc de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Continuous monitoring of glucose with a FreeStyle Libre pro sensor in diabetic and dialysis patients

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date November 9, 2022
Est. primary completion date November 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diabetes without any change in treatment in the last 3 months - Hemodialysis for > 3 months - Recent laboratory HbA1c (< 15 days) Exclusion Criteria: - Patient does not show non-opposition - Skin allergy to the sensor - Sepsis / Acute anaemia

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier Saint Joseph Saint Luc Lyon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference between estimated Hba1c (or Glucose Management Index (GMI)) with FreeStyle Libre Pro sensor and laboratory Hba1c Comparison between estimated HbA1c with 14 days of CGM data and laboratory HbA1c (routine blood test in hemodialysis) in each subject At sensor removal (day 14)
Secondary Time in glucose range Percent (%) time in glucose range of =70 to =180 mg/dL (=3.9 to =10 mmol/L), obtained using professional continuous glucose monitoring (CGM) At sensor removal (day 14)
Secondary Time with Glucose < 70mg/dL % time with glucose <70 mg/dL At sensor removal (day 14)
Secondary Time with Glucose > 180 mg/dL % time with glucose >180 mg/dL At sensor removal (day 14)
Secondary Glucose total coefficient of variation (CV) Glucose total CV (%) At sensor removal (day 14)
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